KR20240058990A - Cover structure for drug delivery device - Google Patents

Abstract

The present disclosure relates generally to drug delivery devices, such as automatic injectors, and in particular to a cover structure configured to surround a drug delivery member at a proximal end of the drug delivery device.

Description

Cover structure for drug delivery device

The present disclosure relates generally to drug delivery devices, such as automatic injectors, and in particular to a cover structure configured to surround a drug delivery member at a proximal end of the drug delivery device.

Many medical conditions require injections. Nowadays, many different injection devices exist, including various types of pen injectors, auto-injectors, and intracorporeal devices. Although many of these devices have enabled significant improvements in the management of many medical conditions, various limitations still exist in current technology. Among these, there are difficulties faced by patients who need frequent injections and especially by patients who need to inject viscous medications. In view of these issues, the applicant has recognized that various developments can be made to help improve drug delivery devices currently on the market, which are presented in more detail below.

The purpose of the present disclosure is to provide a cover structure for a drug delivery device that solves or at least alleviates the problems of the prior art.

According to a first aspect of the present disclosure, a cover structure for a drug delivery device is provided. The cover structure is configured to surround the drug delivery member at the proximal end of the drug delivery device. The cover structure is movable in the axial direction of the drug delivery device between a retracted position where the drug delivery member is exposed at the proximal end of the cover structure and an extended position where the drug delivery member is covered by the cover structure. The cover structure includes a locking structure at a proximal end of the cover structure. The locking structure includes at least one deflectable clip having a distal end and a proximal end and an actuating surface configured to receive an actuating force. The at least one deflectable clip can be arranged in a neutral position preventing axial movement of the cover structure from the extended position to the retracted position. The deflectable clip can also be arranged in a deflection position that is reachable when acting on the operating surface and allows the cover structure to move axially towards the retracted position. The deflectable clip is configured to transition from a neutral position to a deflected position when an actuating force is applied to the actuating surface starting at the proximal end and moving toward the distal end.

Embodiments of the present disclosure provide an advantageous cover structure that allows the drug delivery member to be exposed such that the drug delivery device is activated only when at least one deflectable clip is pushed into a biased state. In other words, it can be ensured that the absence of drug delivery, for example needles, are not exposed in unintended cases and therefore do not potentially cause injury. Additionally, the locking structure forces the user to take appropriate action to use the drug delivery device. For example, the locking structure may be releasable by a cooperating structure of the drug delivery assistant device acting on the actuating surface, thereby allowing the user to use the drug delivery assistant device, advantageously ensuring that the drug is properly delivered to the user. can do.

In this disclosure, when the term “distal direction” is used, it refers to the direction away from the site of dose delivery during use of the drug delivery device. When the term “distal portion/end” is used, it refers to the portion/end of the delivery device or member of the delivery device that is located furthest from the dose delivery site, during use of the drug delivery device. Correspondingly, when the term “proximal direction” is used, it refers to the direction towards the site of dose delivery during use of the drug delivery device. When the term “proximal portion/end” is used, it refers to the portion/end of the delivery device or member of the delivery device that is located closest to the dose delivery site during use of the drug delivery device.

Additionally, the terms “longitudinal,” “longitudinally,” “axially,” or “axially” mean proximally, typically in the direction of the longest extension of the device and/or component, along the device or component of the device. Refers to the direction extending from the end to the distal end.

Similarly, the terms “transverse,” “transverse,” and “transversely” refer to a direction generally perpendicular to the longitudinal direction.

Additionally, the terms "circumferentially", "circumferentially", and "circumferentially" refer to a circumferential direction or circumferentially about an axis, typically a central axis extending in the direction of the longest extension of the device and/or component. Similarly, the terms "radial" or "radially" refer to a direction extending radially about an axis, and the terms "rotation", "rotational" and "rotational" refer to rotation about an axis. .

The same directional terminology is used to describe other components such as pads; For example, the proximal end of the pad is the portion of the pad closest to the dose delivery site (injection site), and the distal end of the pad is the portion of the pad furthest from the dose delivery site. In the figure, the longitudinal direction is the direction of axis 102, and the corresponding circumferential direction 31 and radial direction 32 with respect to axis 102 are also shown.

When the phrases 'at the site of injection' or 'at the site of dose delivery' are used in this application, this generally means that the drug delivery device (e.g. needle) is placed on the patient along with the surrounding area, e.g. the area to which a pad is attached. It refers to the point where it enters.

According to one embodiment, the at least one deflectable clip may be configured to transition to a deflected state by cooperation with a columnar structure acting on an actuating surface of an attachment portion of a pad configured to receive a drug delivery device.

Such pads are attached to the user's injection site when in use. The pad includes an attachment portion that, when in use, can lock the drug delivery device in place until the user detaches the drug delivery device. Advantageously, the columnar structure of the pad acts on the actuating surface when the drug delivery device is inserted into the attachment portion, whereby the cover structure is transferred to the retracted position. The deflectable clip is particularly configured to be deflected by means of a columnar structure in the attachment portion. Accordingly, the user is encouraged to use the pad provided, for example, to help the user keep the drug delivery device in place at the injection site for a sufficient duration to ensure that the drug is delivered properly.

According to one embodiment, the cylindrical structure may be a cylindrical structure, and the locking structure is configured to fit inside the cylindrical structure. The cylindrical structure advantageously provides rotational symmetry, so that the circumferential orientation of the cover structure in the cylindrical structure is of less or no importance in causing deflection of the clip.

According to one embodiment, when the at least one deflectable clip is in the neutral position and the cover structure is moved toward the retracted position, the at least one deflectable clip may be configured to abut a stationary element of the drug delivery device. The stop element is preferably positioned distal to the at least one clip when the cover structure is in the extended position.

According to one embodiment, the stop element may be part of the housing of the drug delivery device.

According to one embodiment, the distal end of the at least one deflectable clip may be configured to abut a stop element to prevent the cover structure from moving into the retracted position.

According to one embodiment, the deflectable clip may be configured such that when deflected transversely inward, the stop element is released to enable movement of the cover structure towards the retracted position. Accordingly, the deflectable clip protrudes radially outward in the neutral position.

According to one embodiment, the locking structure may include at least two deflectable clips arranged symmetrically along the circumference of the cover structure.

According to one embodiment, each of the at least one deflectable clips may include a ramp surface extending from a proximal end to a distal end of the clip, and the ramp surface may be configured to slide on the cylindrical structure of the attachment portion of the pad.

According to one embodiment, the at least one deflectable clip includes a fixed proximal end and a free distal end, wherein when the at least one deflectable clip is transitioned from the neutral position to the biased position, the free distal end is relative to the fixed proximal end. It is possible to move.

According to one embodiment, the at least one deflectable clip is made by cutting through the cover structure. This provides a relatively simple way to provide the cover structure and clip as an integrated single structure.

According to one embodiment, when the at least one deflectable clip is in the neutral position and the cover structure is in the extended position, the at least one deflectable clip is positioned proximally outwardly of the housing of the drug delivery device.

Drug delivery devices comprising the cover structure of any of the embodiments disclosed herein are also provided.

According to a second aspect of the present disclosure, a pad is provided that extends along an axis from a proximal end to a distal end, the proximal end being the end of the pad adjacent the injection site when the pad is in use. The pad includes an attachment portion configured to receive a drug delivery device and a columnar structure arranged in the attachment portion. The columnar structure is configured to receive and push the locking structure of the cover structure included in the drug delivery device when in use and when the drug delivery device is moved from the attachment portion into place, whereby the locking structure allows the cover structure to From a neutral position where the locking structure prevents axial movement towards the retracted position when in the extended position, the cover structure is moved to a biased position where it is permitted to move axially towards the retracted position at the attachment portion.

This provides an advantageous pad comprising a columnar structure capable of cooperating with the locking structure of the cover structure described in the first aspect. These pads ensure that the drug delivery device remains in the appropriate position for drug delivery. Furthermore, the columnar structure is specifically designed to enable actuation of the locking structure only when the drug delivery device is in place at the attachment portion, thereby encouraging the user to use the pad.

According to one embodiment, the proximal scanning surface may include adhesive. Adhesive is provided to attach the pad to the injection site.

This aspect provides similar advantages as discussed above with respect to the first aspect.

According to a third aspect of the present disclosure, a cover structure for a drug delivery device is provided, the cover structure being configured to surround a drug delivery member at a proximal end of the drug delivery device. The cover structure is movable in the axial direction of the drug delivery device between a retracted position where the drug delivery member is exposed at the proximal end of the cover structure and an extended position where the drug delivery member is covered by the cover structure. The cover structure includes a pad integrated with the cover structure, the pad extending along an axis from a proximal end to a distal end, the proximal end being the end of the pad adjacent the injection site when the pad is in use.

Users of drug delivery devices are encouraged to use pads to facilitate the task of injecting drugs, especially to ensure that the drug delivery device remains in place at the injection site for a sufficient period of time. An embodiment of the third aspect of the present disclosure provides a cover structure incorporating a pad to ensure that the pad is employed when using the drug delivery device.

According to one embodiment, the proximal scanning surface of the pad may include adhesive.

According to one embodiment, the cover structure may include a release mechanism that, when actuated, releases the cover structure from the retracted position.

According to one embodiment, the release mechanism may be configured to latch on a locking protrusion of the housing of the drug delivery device.

According to one embodiment, the cover structure may include resilient tabs configured to apply a transverse force to the housing of the drug delivery device.

According to one embodiment, the pad and the cover structure may be formed as one piece.

According to one embodiment, the cover structure may include a drug delivery member arranged to be covered by a removable protective cap at a proximal end of the pad.

According to one embodiment, the drug delivery member may be configured to completely transition into the interior of the cover structure when the removable protective cap is removed.

According to one embodiment, the cover structure may include a receiving portion configured to connect the drug delivery member to the drug container of the drug delivery device when the drug delivery device is attached to the cover structure.

This third aspect provides similar advantages to those discussed above with respect to the first and second aspects.

In general, all terms used in the claims should be construed according to their ordinary meaning in the art, unless otherwise explicitly provided herein. All references to “a member, device, component, means, etc.” should be construed as referring to at least one example of a member, device, component, means, etc., unless explicitly stated otherwise.

Now, specific embodiments of the inventive concept will be described by way of example with reference to the accompanying drawings:
1 is a perspective view of a pad and an automatic injector according to an embodiment of the present disclosure;
Figure 2 is a side view of the pad and auto-injector of Figure 1;
Figure 3A is a cross-sectional view of the auto-injector and pad of Figures 1 and 2 before the auto-injector is engaged with the pad;
Figures 3B and 3C are cross-sectional views of the auto-injector and pad of Figures 1 and 2 when the auto-injector is inserted into the attachment portion of the pad;
4A and 4B are cross-sectional views of an auto-injector according to an embodiment;
5A-5D show cross-sectional views of further possible embodiments of the present disclosure.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The inventive concept will now be more fully described below with reference to the accompanying drawings, in which exemplary embodiments are shown. However, the inventive concept may be embodied in many different forms, and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are intended to be used so that this disclosure will be thorough and complete, and will provide those skilled in the art with the inventive concept. It is provided as an example to fully convey its scope. Like reference numerals refer to like elements throughout the specification.

1 and 2 show an example of a drug delivery device 110 and a pad 100 according to an embodiment of the present disclosure. Pad 100 extends along axis 102 from proximal end 104 to distal end 106. Proximal end 104 is the end of the pad adjacent to the injection site when the pad is in use. The injection site is understood as the site of drug delivery.

Pad 100 includes an attachment portion 108 configured to receive a drug delivery device 110, such as an auto-injector or pen syringe.

The drug delivery device 110 of FIGS. 1 and 2 extends from the proximal end 112 to the distal end 114 relative to the axis 102. Drug delivery device 110 includes a housing 116, a window 118, a needle 120, and a cover structure 122 configured to cover the needle 120. Drug delivery device 110 also includes an attachment portion 124 configured to engage an attachment portion 108 of pad 100.

The attachment portion 108 of the pad 100 is equipped with a locking mechanism 126 for releasably locking the drug delivery device 110 to the pad 100. The locking mechanism 126 can be configured in a variety of ways, for example as a friction lock where the movable arm 127 applies a retention force to the attachment portion 124 of the drug delivery device 110, or as a drug delivery device. A protrusion on the proximal end of the housing 116 of 110 engages a corresponding portion on the attachment portion 108 of the pad 100 to provide a snap-fit lock that locks the drug delivery device 110 in place. ) can be configured as.

Pad 100 also includes a release button 128 configured to selectively release the drug delivery device from attachment portion 108 by actuation.

2 shows drug delivery device 110 attached to pad 100 at attachment portion 108. Needles 120 extend outwardly from the proximal end 104 of pad 100. In this state, the cover structure, sometimes referred to as a needle guard, is in a retracted position, thereby exposing the needle 120. When drug delivery device 110 is not attached to attachment portion 108, needle 120 preferably does not remain in this exposed state. Additionally, when using the drug delivery device 110 to deliver drug to the injection site, it is preferred that the pad 100 be used, and thus the user is encouraged or even forced to use the pad to ensure proper and safe drug delivery. It is desirable to be

In order to solve the above problem, the cover structure 122 is provided with a locking structure, which will now be described in more detail.

Reference is now made to FIGS. 3A-3C, which each illustrate a cross-section of the cover structure 122 of the drug delivery device 110. Cover structure 122 is configured to surround drug delivery member 120 at the proximal end 112 of drug delivery device 110. The cover structure generally has a position between a retracted position where the drug delivery member 120 is exposed at the proximal end 112 of the cover structure 122 and an extended position where the drug delivery member 120 is covered by the cover structure 122. Operable to be axially movable along axis 102 (better shown in Figure 1) of drug delivery device 110. In the extended position of the cover structure 122, the drug delivery member 120 is covered and is prevented from causing unnecessary injury. Cover structure 122 is positioned proximally to drug delivery member 120 in the extended position.

Cover structure 122 includes a locking structure 130 at a proximal end 112 of the cover structure. The locking structure 130 includes at least one deflectable clip 132 having a distal end 136 and a proximal end 138 and an actuation surface 134 configured to receive an actuation force. At least one deflectable clip 132 can be arranged in a neutral position that prevents the cover structure 122 from moving axially from an extended position to a retracted position, as shown in Figure 3A, where the clip 132 Adjacent to the stop element 142.

The deflectable clip 132 has an achievable deflection position (FIGS. 3B and FIG. (shown in 3c) may be further arranged. Clip 132 is configured to transition from a neutral position to a biased position when an actuation force is applied to actuation surface 134 starting from proximal end 138 and moving toward distal end 136 . Preferably, a sliding force is applied to the actuating surface starting from the proximal end 138 and sliding towards the distal end 136.

In the neutral position, the actuating surface 134 of the deflectable clip 132 extends from the proximal cylindrical portion 140 of the cover structure 122 at the distal end 136 of the clip relative to the proximal end 138 of the clip 132. It reaches progressively further radially. In the neutral position, the operating surface 134 is inclined relative to the longitudinal axis 102 of the drug delivery device 110.

Referring now specifically to FIG. 3A , the proximal end 112 of the drug delivery device 110 is shown just before insertion into the attachment portion 108 of the pad 100. The needle 120 is covered by or received within the cover structure 122, here in an extended position. The cover structure 122 is slideable within the housing 116 in the longitudinal direction of the drug delivery device 110 so that it can be moved between an extended and retracted position. Cover structure 122 may be a spring biased toward an extended position.

Cover structure 122 is generally cylindrical with a hollow interior space for receiving needle 120. Clip 132 also provides a tapered shape for a portion of cover structure 122, with the wider portion of the tapered shape being at the distal end 136 of clip 132.

Located at the most proximal end of the cover structure 122 is a cylindrical portion 140, which is provided to facilitate accurate fitting of the cover structure 122 to the attachment portion 108 of the pad 100. do. The cylindrical portion 140 is arranged proximally with respect to the clip 132 .

In this neutral position of the clip 132, the clip 132 abuts the stop element 142 of the drug delivery device 110 and prevents the cover structure 122 from moving toward the retracted position. In this particular embodiment, it is the distal end 136 of at least one clip 132 that is configured to abut the stop element 142 . Additionally, the deflectable clip 132 is located proximally outside the housing 116 of the drug delivery device 110.

When the clip 132 is biased radially inward as indicated by arrow 144, the clip is biased laterally inward to a position laterally closer to the longitudinal axis 102 than the stop element 142, thereby covering the The structure 122 is no longer prevented from moving longitudinally towards the retracted position by the stop element 142, which will be explained in more detail herein.

Pad 100 includes an attachment portion 108 configured to receive drug delivery device 110. More specifically, in use, the cover structure 122 is guided by the cylindrical portion 140 and inserted into the attachment portion 108. The proximal end 112 of the housing 116 containing the stop element 142 also fits inside the attachment portion.

A columnar structure 146 is arranged at the attachment portion 108. 3B, when the drug delivery device 110 is inserted into the attachment portion 108, the at least one deflectable clip 132 is biased by cooperation with the columnar structure 146 of the attachment portion 108. transitions to a state To this end, the cylindrical structure 146 acts on the actuating surface 134 to deflect the clip 132 as indicated by arrow 150. In this exemplary embodiment, the operating surface 134 is directed transversely and radially outwardly. In other words, the columnar structure 146 acts radially toward the longitudinal axis 102 of the drug delivery device 110. Columnar structure 146 slides on actuating surface 134 from proximal end 138 toward distal end 136.

Accordingly, the columnar structure 146 is configured to receive and push the clip 132 of the locking structure 130 of the cover structure 122 when the drug delivery device 110 is moved into place in the attachment portion 108. . In this embodiment, the columnar structure 146 is a cylindrical structure, and the locking structure is configured to fit inside the cylindrical structure.

As discussed above, as a result, the locking structure moves the cover structure 122 from a neutral position, which prevents the locking structure 122 from moving axially toward the retracted position when the cover structure 122 is in the extended position. 122) is moved from the attachment portion to a biased position that allows it to move axially toward the retracted position.

In Figure 3B, the cover structure 122 is still in the extended position and the clip 132 is in the biased position. When the pad 100 and drug delivery device 110 are in use and the cover structure 122 is pushed toward the proximal support 148 of the attachment portion 108 adjacent the injection site, the cover structure 122 is in an extended position. It is possible to move longitudinally toward (shown in Figure 3c). The stop element 142 is moved into a space transversely outside the columnar structure 146 . Here, the movable arm 127 of the locking mechanism 126 applies a retention force to the attachment portion 124 of the drug delivery device 110.

The clip is preferably elastic. Accordingly, clip 132 springs back to a neutral position when released by stop element 142.

The locking structure 130 preferably includes at least two deflectable clips 132 arranged symmetrically along the circumference of the cover structure 122 .

To facilitate biasing movement of the clips 132, each clip 132 includes a ramp surface 152 extending from the proximal end 138 to the distal end 136, where the ramp surface 152 extends from the pad. It is configured to slide on the cylindrical structure of the attachment portion. This ramp surface 152 may be the entire operating surface 134, or the operating surface 134 may include the ramp surface 152.

The proximal end 138 of the clip is a fixed end about which the clip can rotate, as indicated here by the arrow. For this purpose, the distal end 136 is a free end that can move relative to the fixed end when the at least one deflectable clip 132 is transitioned from the neutral position to the deflected position.

One way to realize the clip 132 is to make the clip by cutting through the cover structure. Accordingly, clip 132 and cover structure 122 are made as one integral part by cutting through the material of cover structure 122 to form the clip. The cut may be made in a U shape, for example.

4A and 4B illustrate additional aspects of the present disclosure relating to a cover structure 222 for a drug delivery device 110. As in the first aspect, the cover structure 222 is configured to surround the drug delivery member 120 at the proximal end 112 of the drug delivery device 110.

Also, in this embodiment, the cover structure 222 has a contracted position (shown in Figure 4B) where the drug delivery member 120 is exposed at the proximal end 112 of the cover structure and the drug delivery member 120 is positioned at the cover structure. The drug delivery device 210 is axially movable between extension positions (shown in FIG. 4A ) covered by 222 .

Cover structure 222 includes a pad 200 integrated with cover structure 222 . Similar to pad 100 discussed in connection with the previous figure, pad 200 extends along axis 102 from proximal end 104 to distal end 106, where proximal end 104 is the pad used. It is the end of the pad 200 adjacent to the injection site when in use.

The cover structure 222 is a cylindrical structure with a hollow internal space for accommodating the drug delivery member 120. Accordingly, cover structure 222 may have a tubular body.

The cover structure 222 is arranged coaxially with the cylindrical outer wall 206 of the attachment portion 208 of the pad 200 extending proximally from the distal end 106 of the pad.

The cover structure 222 is located inside the cylindrical outer wall 206 of the attachment portion 208 and has a smaller diameter than the cylindrical outer wall 206.

Additionally, the cover structure 222 is fixedly attached to the pad 200, for example, to the attachment portion 208. Here, cover structure 222 reaches proximal end 104 of pad 200.

In Figure 4A, cover structure 222 is in an extended position with needle 120 covered. As the drug delivery device is moved proximally toward the injection site, the cover structure 222 is moved longitudinally in the distal direction, exposing the needle 120 to the proximal end 104 of the pad (see Figure 4B). ). In this retracted position, the housing 216 of the drug delivery device 210 has moved into the space between the cover structure 222 and the cylindrical outer wall 206 of the attachment portion 208. In other words, in this retracted position, the housing 216, cover structure 222, and cylindrical outer wall 206 are coaxially oriented with respect to each other.

Preferably, the pad 200 and the cover structure 222 are manufactured as one piece. For example, pad 200 with attachment portion 208 may be molded together with cover structure 222. Cover structure 222 is part of drug delivery device 110.

Preferably, the proximal scanning surface 202 of the pad includes adhesive. The proximal injection surface 202 is in contact with the injection site when the drug delivery device 210 is in use.

Cover structure 222, here comprising integral pad 200 and attachment portion 208, further includes a locking mechanism 126 that releases cover structure 222 from its retracted position when activated.

The locking mechanism 126 can be configured in a variety of ways, for example as a friction lock in which a movable arm 127 applies a holding force to the housing 216 of the drug delivery device 210, or as a friction lock on the housing 216 of the drug delivery device 210. A protrusion on the proximal end of 216 may be configured as a snap-fit lock that engages a corresponding portion on attachment portion 208 of pad 200 to lock cover structure 222 in the retracted position.

Pad 100 also includes a release button 128 configured to selectively operate to release housing 216 and thereby release cover structure 222 from its retracted position.

Housing 216 includes a locking protrusion 220 at a proximal end 112 of the housing. The protrusion 220 extends transversely away from the longitudinal axis 102 and latches on the proximal end shoulder 228 of the release mechanism movable arm 127. When the release button is pressed, shoulder 228 moves away from housing 216 to release protrusion 220.

Additionally, to improve locking the housing 216 and maintaining the cover structure 22s in the retracted position, a set of elastic tabs attached to the cover structure in the space between the cover structure 222 and the outer wall 206 ( 230) is configured to apply a transverse force to the housing 216 of the drug delivery device.

5A-5D show cross-sections of one possible embodiment of the present disclosure wherein the drug delivery device 110 has a drug container 304, e.g., a cartridge, in its body 306, and the pad 100 contains the drug. It includes a needle 120, which is a delivery member.

Pad 100 includes an attachment portion 208 discussed in connection with other embodiments described herein. However, in this embodiment the attachment portion itself, more specifically the cylindrical wall 206, serves as the cover structure. However, the cover structure is not initially part of the drug delivery device, but as discussed below, once in use, the body of the drug delivery device 110 is attached to the needle assembly 308 received in the attachment portion 208. do.

The needle 120 is arranged in a through hole of the needle hub 310, which has a tubular shape. The needle 120 extends beyond the proximal end 104 of the pad 100 and is covered by a removable protective cap 302 .

FIG. 5B shows the needle 120 being fully recessed into the interior of the cover structure 322 once the removable protective cap 302 is removed. Transfer of the needle can be realized in various ways. In one possible implementation, when the cap 302 is rotated, the needle hub 310 is also rotated due to the structural coupling therebetween.

For example, the distal engagement member 311 of the hub 310 is a threaded member designed to interact with the threads 314 of the central passage of the retainer member 312. The threads 316 between the cap 302 and the retainer member 312 have a different pitch direction than the threads 314 between the hub 310 and the retainer member 312. Accordingly, when the cap 302 is rotated to remove the cap 302 proximally from the retainer member 312, rotation of the hub 310 causes the hub 310 to move distally into the retainer member 312. Let it be done. It should be understood that this rotation type of needle isolation protection is shown as an example only, and that other possible ways of realizing the needle being moved into the attachment portion 208 are possible.

The retainer member 312 has a tubular receiving portion 318 configured to receive the needle 120 and connect to the drug container 304 of the drug delivery device 110 when attached to the cover structure 322, which is a cylindrical wall 206. Includes. As shown in Figure 5C, the body 306 of the drug delivery device is pushed into the retainer member 312 as indicated by arrow 320, whereby the needle 120 is pushed into the proximal end of the pad 100. 104) and protrudes outwards. Accordingly, the cover structure 322 is in the retracted position.

Figure 5D shows the used drug delivery device 110 with the needle covered by the cover structure 322, here in the extended position. After use, the user may use the locking mechanism 126 to release the drug delivery device 110 and dispose of the drug delivery device 110 and pad 300.

The pads described herein can be made from transparent materials. Additionally, the sidewall of the attachment portion may include an opening that defines a window proximate the base of the attachment portion adjacent the pad surface. Prior to use, the instructions instruct the patient to ensure that the cover structure is fully depressed when using the auto-injector. When an automatic injector is used in combination with an injection support pad, the patient can check the status of the cover structure through the window.

The pads disclosed herein may include embedded electronics comprising different units:

A sensor unit capable of recognizing injection events such as insertion of the automatic injector into the attachment portion, start of injection and end of injection.

A memory unit configured to store data recorded during scanning.

A connected unit configured to transmit stored data directly to a smart device or network.

A processing unit that is configured to control the entire system and processes data before transmitting it.

A user interface unit configured to provide feedback to the patient, such as status LEDs, tactile and/or auditory feedback.

When the auto-injector is placed in the attachment area, sensors inside the support pad are configured to recognize the event and provide feedback to the patient through tactile/visual or auditory elements.

When the injection is complete, the sensor is configured to recognize the event and provide feedback back to the patient. Additionally, the collected data can be stored in the memory unit and transmitted to a smart device/network via the connectivity unit after the scanning event ends.

The sensor may be one of a mechanical switch, a Hall effect sensor, an accelerometer, or a combination thereof.

A mechanical switch, Hall effect sensor, or accelerometer can be used to detect insertion of the auto-injector into the injection port.

An accelerometer may be used to detect scanning events.

Possible wireless communication methods include Bluetooth and cellular networks.

Bluetooth connectivity requires the smart device to transmit stored data to the network and requires a pairing action between the support pad and the smart device before the support pad can be used. However, Bluetooth connectivity is a cheaper alternative and requires less space on the PCB.

Cellular networks do not require any pairing process, can be used as plug-n-play devices, and do not require pre-configuration, but are more expensive and require more space on the PCB.

Depending on the requirements of the product, either of those two technologies may be used.

Such processing units may include logic circuits or control units including microprocessors, microcontrollers, programmable digital signal processors, or other programmable devices. Each processing circuit may additionally or alternatively include an application-specific integrated circuit, a programmable gate array or programmable array logic, a programmable logic device, or a digital signal processor. If the processing circuit includes a programmable device, such as the above-mentioned microprocessor, microcontroller, or programmable digital signal processor, the processor may further include computer-executable code that controls the operation of the programmable device.

In the above, the inventive concept has been mainly explained with reference to several examples. However, as will be readily appreciated by those skilled in the art, embodiments other than those disclosed above are equally possible within the scope of the inventive concept as defined by the appended claims.

Some aspects are described in the sections below.

Item 1. In the cover structure (222, 322) for the drug delivery device (210),

The cover structure is configured to surround the drug delivery member (120) at the proximal end (112) of the drug delivery device,

The cover structure is movable in the axial direction of the drug delivery device between a contracted position where the drug delivery member is exposed at the proximal end of the cover structure and an extended position where the drug delivery member is covered by the cover structure,

The cover structure includes a pad (200) integrated with the cover structure, the pad extending along an axis (102) from a proximal end (104) to a distal end (106), the proximal end being used by the pad. A cover structure, the end of the pad adjacent to the injection site when in use.

Item 2. The cover structure of item 1, wherein the proximal scanning surface (202) of the pad comprises adhesive.

Item 3. The cover structure of item 1 or item 2, comprising a locking mechanism (126) that, when actuated, releases the cover structure from the retracted position.

Item 4. The cover structure of item 3, wherein the locking mechanism (126) is configured to latches on the locking protrusion (220) of the housing of the drug delivery device.

Item 5. The cover structure of any one of items 1 to 4, comprising an elastic tab (230) configured to apply a transverse force to the housing (216) of the drug delivery device.

Item 6. The cover structure according to any one of items 1 to 5, wherein the pad and the cover structure are formed as one piece.

Item 7. The cover structure of any one of items 1 to 5, wherein the cover structure is part of the drug delivery device.

Item 8. The cover structure (322) according to any one of items 1 to 6, comprising the drug delivery member arranged to be covered by a removable protective cap (302) at the proximal end of the pad.

Item 9. The cover structure of item 8, wherein the drug delivery member is configured to fully transition into the interior of the cover structure when the removable protective cap is removed.

Item 10. The method of item 8 or item 9, comprising a receiving portion (318) configured to connect the drug delivery member to a drug container (304) of the drug delivery device when the drug delivery device is attached to the cover structure. Cover structure.

Item 11. The cover structure of any one of items 8-10, wherein the body (306) of the drug delivery device comprising a drug container is inserted into the cover structure when in use.

Claims (15)

In the cover structure 122 for the drug delivery device 110,
The cover structure is configured to surround the drug delivery member (120) at the proximal end (112) of the drug delivery device,
The cover structure moves in the axial direction of the drug delivery device between a retracted position where the drug delivery member 120 is exposed at the proximal end of the cover structure and an extended position where the drug delivery member is covered by the cover structure. It is possible,
The cover structure includes a locking structure (130) at a proximal end of the cover structure, the locking structure having at least one distal end (136) and a proximal end (138) and an actuation surface (134) configured to receive an actuation force. comprising a deflectable clip (132), wherein the at least one deflectable clip is arranged in a neutral position to prevent axial movement of the cover structure from an extended position to a retracted position, the deflectable clip further comprising: Arrangeable in a deflection position that is reachable when acting on the actuating surface and allows the cover structure to move axially toward a retracted position, the deflectable clip starting from the proximal end (138) and extending to the distal end ( configured to transition from a neutral position to a biased position when an operating force moving toward 136) is applied to the operating surface.
Cover structure. According to claim 1,
The at least one deflectable clip is configured to be transitioned to a biased state by cooperation with a columnar structure 146 acting on the actuating surface of the attachment portion 108 of the pad 100 configured to receive the drug delivery device. felled
Cover structure. The method of claim 1 or 2,
The cylindrical structure is a cylindrical structure, and the locking structure is configured to fit inside the cylindrical structure.
Cover structure. The method according to any one of claims 1 to 3,
When the at least one deflectable clip 132 is in the neutral position and the cover structure is moved toward the retracted position, the at least one deflectable clip 132 abuts against the stop element 142 of the drug delivery device. configured to
Cover structure. According to claim 4,
The stop element is part of the housing 116 of the drug delivery device.
Cover structure. The method of claim 4 or 5,
The distal end 136 of the at least one deflectable clip is configured to abut the stop element.
Cover structure. The method according to any one of claims 1 to 6,
The deflectable clip is configured such that, when deflected transversely inward, the stop element is released to enable movement of the cover structure towards the retracted position.
Cover structure. The method according to any one of claims 1 to 7,
comprising at least two deflectable clips arranged symmetrically along the circumference of the cover structure.
Cover structure. The method according to any one of claims 1 to 8,
Each of the at least one deflectable clips includes a ramp surface (152) extending from a proximal end to a distal end, wherein the ramp surface (152) is configured to slide on the cylindrical structure of the attachment portion of the pad.
Cover structure. The method according to any one of claims 1 to 9,
The at least one deflectable clip includes a fixed proximal end (138) and a free distal end (136), wherein when the at least one deflectable clip transitions from a neutral position to a biased position, the free distal end is converted to a fixed proximal end (136). movable about the proximal end
Cover structure. The method according to any one of claims 1 to 10,
The at least one deflectable clip is made by cutting through the cover structure.
Cover structure. The method according to any one of claims 1 to 11,
When the at least one deflectable clip is in the neutral position and the cover structure is in the extended position, the at least one deflectable clip is positioned proximally outside the housing 116 of the drug delivery device.
Cover structure. Comprising the cover structure according to any one of claims 1 to 12.
Drug delivery device. A pad (100) extending along an axis (102) from a proximal end (104) to a distal end (106), wherein the proximal end is the end of the pad adjacent an injection site when the pad is in use. ) in,
an attachment portion (108) configured to receive a drug delivery device (110);
A columnar structure (146) arranged at the attachment portion, the columnar structure being included in the drug delivery device when in use and when the drug delivery device (110) is moved into place at the attachment portion. configured to receive and push the locking structure 130 of the cover structure 122, whereby the locking structure moves axially toward the retracted position when the cover structure is in the extended position. from a neutral position preventing the cover structure from being moved to a biased position allowing the cover structure to move axially toward a retracted position at the attachment portion.
pad. In the cover structure (222, 322) for the drug delivery device (210),
The cover structure is configured to surround the drug delivery member (120) at the proximal end (112) of the drug delivery device,
The cover structure is movable in the axial direction of the drug delivery device between a contracted position where the drug delivery member is exposed at the proximal end of the cover structure and an extended position where the drug delivery member is covered by the cover structure,
The cover structure includes a pad (200) integrated with the cover structure, the pad extending along an axis (102) from a proximal end (104) to a distal end (106), the proximal end being used by the pad. The end of the pad adjacent to the injection site when
Cover structure.